- Helicore’s first-in-human study is designed to evaluate the safety and tolerability of HCR-188 in a single and multiple ascending dose study
- Top-line safety data anticipated in the second half of 2025
SOUTH SAN FRANCISCO, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Helicore Biopharma Inc., a clinical stage biopharmaceutical company focused on the discovery and development of first-in-class glucose-dependent insulinotropic peptide (GIP) antagonists for obesity and related conditions, announced today that the first participant has been dosed in its first-in-human Phase 1 study of HCR-188 for the treatment of obesity. HCR-188 is a first-in-class monoclonal antibody (mAb) designed to bind to circulating GIP ligand, unlike antibodies that bind the GIP receptor (GIP receptor antagonists).
“Initiating this first-in-human study for GIP ligand binding with HCR-188, our humanized monoclonal antibody, is a significant milestone in the development of GIP ligand binding as a new mechanism of action in obesity treatment,” said Gerrit Klaerner, PhD, President and CEO of Helicore. “While we do not expect to see efficacy signals for weight loss given the known time to onset of GIP antagonism, demonstrating the safety and tolerability of GIP ligand binders in this SAD/MAD study will establish the foundation for further advancement of our product portfolio.”
About HCR-188
HCR-188 binds circulating GIP ligand, which is expressed exclusively by K cells in the small intestine. Circulating GIP binds to GIP receptors (GIPR), which are expressed throughout the body, including in fat and in deep brain structures. HCR-188, unlike GIPR antagonists, has the potential to reduce circulating GIP and, consequently, GIP available to transit into the central nervous system. Thus, HCR-188 and conjugates in development may uniquely prevent GIP signaling in the brain, potentially restoring leptin sensitivity that may support increased satiety as well as reduced consumption and fat deposition.
About the Phase 1 Study
This is a first-in-human Phase 1 randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in volunteers who are overweight or obese and who do not have diabetes mellitus (ClinicalTrials.gov identifier NCT06845943). The primary aim of this study is to evaluate the safety and tolerability of HCR-188 administered as subcutaneous injection(s) at different dose levels. In addition to safety and pharmacokinetics, the study will examine the effect of HCR-188 on its target (GIP) and on inflammatory and metabolic markers such as lipids and glucose, as well as hormones affecting glucose and lipid metabolism and caloric intake. Based on the novel mechanism of action of HCR-188 as a monoclonal antibody binding GIP ligand, an observable effect on weight loss in the 4-week MAD treatment period is not expected.
Top-line safety data are anticipated in the second half of 2025.
About Helicore Biopharma Inc.
Helicore Biopharma is a clinical stage biopharmaceutical company focused on the discovery and development of a portfolio of first-in-class glucose-dependent insulinotropic peptide (GIP) antagonists for obesity and related conditions. The company’s novel approach to GIP antagonism — monoclonal antibodies that bind circulating GIP ligand — serves as the backbone of a highly modular platform for anti-obesity medicines that have the potential to offer improved efficacy, dosing and tolerability.
More information is available at www.helicore.com or you can find us on LinkedIn.
Media contact:
Dan Boyle, Scient PR
dan@scientpr.com
